DTX Studio 助手
K号: K252086 · 2025-11-17
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器械摘要
DTX Studio Assist is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare C/O Medicim NV. It received FDA 510(k) clearance on 2025-11-17 under 510(k) number K252086. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DTX Studio Assist?
DTX Studio Assist is a medical device that received FDA 510(k) clearance on 2025-11-17. The listed applicant is Nobel Biocare C/O Medicim NV. The 510(k) number is K252086.
When did DTX Studio Assist receive FDA 510(k) clearance?
DTX Studio Assist received FDA 510(k) clearance on 2025-11-17, under 510(k) number K252086.
Who is the listed applicant for DTX Studio Assist?
The FDA 510(k) record lists Nobel Biocare C/O Medicim NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DTX Studio Assist?
The FDA product code for DTX Studio Assist is MYN.
相关临床试验
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相关器械（代码：MYN）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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